Job Title: Senior Engineer
Location: Thousand Oaks, CA (Hybrid)
Pay Rate: $48/hr – $50/hr
Job Summary:
- We are seeking a dedicated Senior Engineer with a strong background in Mechanical, Biomedical, or Manufacturing engineering. The successful candidate will be responsible for engineering activities related to the development, qualification, validation, and transfer of GMP physical test methods for combination products, devices, primary container, and secondary packaging components. This role requires the ability to manage multiple projects simultaneously, involving new or improved product, process, tooling, or equipment to enhance product quality and reliability.
Responsibilities:
- Develop and transfer new combination product test methods to QC or manufacturing, ensuring six sigma processes and documentation are in place.
- Implement projects in line with company procedures, ensuring timely completion within budget.
- Apply core engineering principles to develop physical test methods for medical device and combination product systems.
- Perform data analysis to support method development, qualification, validation, and transfer.
- Provide expert support for investigations and new process development to improve manufacturing operations.
- Coordinate gauge and equipment development and delivery with selected contractors.
Skills Required:
- Bachelor’s Degree and 5 years of Engineering experience or equivalent.
- Experience in a regulated field (Medical devices, pharmaceutical, Aerospace, etc.).
- Experience with CAD (Solidworks preferred) & fixture or component design.
- Excellent written and verbal communication skills.
- Technical writing experience.
- Experience with process characterization, scale-up, technology transfer, pFMEAs and dFMEAs.
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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